Description

Job Responsibilities

Central Risk Manager (RBQM & Central Monitoring)

Are you an RBQM and Centralized Monitoring expert who thrives at the intersection of clinical quality, risk management, data analytics, and RBM strategy designs?

This is a highly visible opportunity for an experienced Central Risk Manager to serve as a subject matter expert in Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM), and Central Monitoring across complex global clinical trials.

We're looking for a strategic thinker who can assess study protocols, identify critical risks, develop monitoring strategies, and confidently influence both internal stakeholders and sponsors. This is not a role focused solely on execution - it is a consultative subject matter expert position requiring strong business acumen, exceptional communication skills, and the ability to provide recommendations as a trusted expert.

The ideal candidate brings deep RBQM and Central Monitoring expertise, strong analytical capabilities, and the confidence to navigate complex discussions involving study quality, monitoring approaches, resource allocation, and budget considerations.

WHAT MAKES THIS OPPORTUNITY DIFFERENT

• Serve as a recognized RBQM and Centralized Monitoring subject matter expert across global clinical programs
• Influence study quality strategy from protocol review through study execution
• Partner directly with sponsors and senior stakeholders to develop and execute monitoring approaches
• Shape risk-based monitoring strategies that impact study quality, efficiency, resource utilization, and patient safety
• Operate in a highly consultative role with significant visibility and organizational influence
• Leverage advanced analytics and centralized monitoring methodologies to drive proactive risk identification and mitigation
• Collaborate with experienced cross-functional clinical research professionals
• Work at the forefront of evolving RBQM methodologies, technology platforms, data analytics, and emerging innovations within clinical research
• Opportunity to mentor colleagues and help drive continuous improvement across programs and teams

WHAT YOU WILL OWN

Risk-Based Quality Management & Monitoring Strategy

• Review study protocols to identify critical data, processes, risks, and quality considerations
• Lead and facilitate protocol execution risk assessments across cross-functional teams
• Develop and refine Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) strategies
• Draft and support Risk Assessment Categorization Tools (RACTs) and associated risk management documentation
• Identify risk mitigation plans and ensure appropriate oversight throughout study execution

Analytics & Data-Driven Decision Making

• Utilize centralized monitoring technologies and analytics platforms to support risk identification and oversight
• Leverage data-driven insights to guide monitoring strategy decisions
• Ensure monitoring approaches remain aligned with evolving study risks and operational realities
• Recommend strategic adjustments to monitoring activities, resource allocation, and oversight plans when necessary
• Evaluate centralized statistical monitoring outputs and recommend appropriate actions
• Support adoption of innovative technologies and emerging approaches to risk management

Sponsor & Stakeholder Partnership

• Present monitoring strategies, risk assessments, and recommendations to internal stakeholders and sponsors
• Clearly communicate complex risk concepts to diverse audiences
• Present recommendations with confidence while managing questions, challenges, and competing viewpoints
• Build credibility as a trusted advisor capable of influencing strategic decisions
• Facilitate collaborative discussions focused on quality, compliance, efficiency, and patient safety

Cross-Functional Leadership & Oversight

• Collaborate with Clinical Operations, Data Management, Medical Monitoring, Safety, Quality, and other functional teams
• Provide guidance and mentorship regarding RBQM methodologies and monitoring strategies
• Ensure consistency across studies, programs, therapeutic areas, and sponsor engagements
• Escalate risks appropriately and proactively when quality, timeline, budget, or delivery concerns arise
• Support business development activities including strategy discussions, proposal development, and budget input as needed

• WHO YOU ARE

  Required Qualifications

• Bachelor's degree, RN, or equivalent combination of education, training, and clinical research experience
• Significant experience within clinical research, CRO, biotechnology, or pharmaceutical environments
• Deep expertise in Risk-Based Quality Management (RBQM) methodologies
• Strong experience with Risk-Based Monitoring (RBM) strategies and implementation
• Central Monitoring experience or exposure, including methodologies, technologies, and operational execution
• Demonstrated experience conducting study-level risk assessments and developing monitoring strategies
• Strong understanding of ICH-GCP and applicable regulatory requirements
• Excellent verbal and written communication skills with strong English proficiency
• Proven ability to present complex concepts clearly and persuasively
• Strong stakeholder management, negotiation, and influencing capabilities
• Exceptional critical thinking, analytical, and problem-solving skills
• Ability to work independently within fast-paced, evolving environments

• Preferred Backgrounds

  Strong preference will be given to candidates who have operated in strategic or leadership-level roles such as:

• Risk Manager
• RBQM Lead
• Clinical Trial Manager (CTM)
• Central Monitoring Lead
• Project Lead / Clinical Project Manager
• Data Management Lead
• Central Monitoring professional with significant strategic ownership

• TECHNICAL EXPERTISE

  Ideal candidates will have familiarity with:

  Central Monitoring & Analytics Platforms

  Examples include:

• CluePoints
• Spotfire
• Tableau
• Power BI
• Other centralized monitoring and analytics technologies

• While expertise in every platform is not required, candidates should understand:

• How these tools support RBQM and centralized monitoring
• Risk identification methodologies
• Data review workflows
• Analytics-driven decision making

• Data Analytics & Visualization

  Knowledge of:

• Data visualization techniques
• Trend analysis
• Outlier detection
• Data integrity assessment
• Statistical monitoring concepts
• Risk signal detection methodologies

• Additional Technical Expertise

• Advanced Microsoft Excel skills, including pivot tables, filtering, sorting, and data analysis
• Understanding of quality risk management principles
• Familiarity with RACT tools and risk assessment frameworks
• Interest in emerging technologies, AI, and innovation within clinical research

• SUCCESS IN THIS ROLE

  The strongest candidates will be:

• Strategic thinkers who can balance quality, risk, budget, and operational realities
• Confident communicators who can influence without direct authority
• Self-motivated professionals who thrive with autonomy
• Critical thinkers who challenge assumptions and identify better solutions
• Adaptable leaders comfortable navigating ambiguity and change
• Collaborative team players who support colleagues and contribute positively to team culture
• Curious professionals who embrace innovation and continuous learning

• TEAM CULTURE

  This is a highly collaborative, fast-paced team that values partnership, transparency, accountability, and continuous improvement. Team members are expected to communicate openly, support one another, share knowledge, and work together to solve complex challenges.

  While strong technical expertise is essential, success in this role also requires a positive attitude, adaptability, and a willingness to share a one-team mentality. The team values professionals who are collaborative, proactive, and committed to both personal growth and collective success. Strong relationships, teamwork, and mutual respect are considered just as important as subject matter expertise.

  If you're looking for an opportunity to influence study quality strategy, drive risk-based monitoring excellence, partner directly with sponsors, and serve as a trusted RBQM leader within a fast-paced global clinical research environment, this is the kind of role that elevates careers.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary